Promethazine containing dosage form

Abstract

A pharmaceutical dosage form which comprises promethazine and/or a pharmaceutically acceptable salt thereof. The dosage form is capable of providing a promethazine plasma concentration within a therapeutic range for at least about 24 hours per single dose. This Abstract is neither intended to define the invention disclosed in this specification nor intended to limit the scope of the invention in any way.

1 . A pharmaceutical dosage form which comprises at least one of promethazine and a pharmaceutically acceptable salt thereof, wherein the dosage form is capable of providing a promethazine plasma concentration within a therapeutic range for at least about 24 hours per single dose.  
   
   
       2 . The dosage form of  claim 1 , wherein the dosage form is capable of providing relief from allergy symptoms in a patient in need thereof for at least about 24 hours per single dose.  
   
   
       3 . The dosage form of  claim 1 , wherein the dosage form comprises at least two promethazine formulations which exhibit different release profiles.  
   
   
       4 . The dosage form of  claim 1 , wherein the dosage form comprises an immediate release formulation.  
   
   
       5 . The dosage form of  claim 4 , wherein the dosage form comprises a controlled release formulation.  
   
   
       6 . The dosage form of  claim 1 , wherein the dosage form comprises a solid dosage form.  
   
   
       7 . The dosage form of  claim 6 , wherein the solid dosage form is selected from tablets, capsules and caplets.  
   
   
       8 . The dosage form of  claim 1 , wherein the dosage form comprises a bi-layered tablet.  
   
   
       9 . The dosage form of  claim 8 , wherein the bi-layered tablet comprises an immediate release layer and a controlled release layer.  
   
   
       10 . The dosage form of  claim 9 , wherein each of the immediate release layer and the controlled release layer comprises at least about 25 mg of promethazine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of promethazine.  
   
   
       11 . The dosage form of  claim 8 , wherein the bi-layered tablet comprises a total of at least about 70 mg of promethazine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of promethazine.  
   
   
       12 . The dosage form of  claim 9 , wherein at least one of the controlled release layer and the immediate release layer comprises at least about 40 mg of promethazine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of promethazine.  
   
   
       13 . The dosage form of  claim 1 , wherein the dosage form comprises at least about 70 mg of promethazine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of promethazine.  
   
   
       14 . The dosage form of  claim 1 , wherein the dosage form comprises at least about 90 mg of promethazine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of promethazine.  
   
   
       15 . The dosage form of  claim 1 , wherein the dosage form is capable of providing a promethazine plasma concentration within a therapeutic range within not more than about 1 hour following ingestion thereof.  
   
   
       16 . The dosage form of  claim 1 , wherein the dosage form comprises at least one further drug.  
   
   
       17 . The dosage form of  claim 16 , wherein the at least one further drug is selected from decongestants, antitussives, expectorants, mucus thinning drugs and analgesics.  
   
   
       18 . The dosage form of  claim 17 , wherein the dosage form is capable of providing a plasma concentration of the at least one further drug within a therapeutic range for at least about 24 hours per single dose.  
   
   
       19 . The dosage form of  claim 18 , wherein the at least one further drug is selected from one or more of phenylephrine, pseudoephedrine, phenylephrine, pseudoephedrine, codeine, dihydrocodeine, hydrocodone, dextromethorphan, carbetapentane, guaifenesin, acetaminophen, aspirin, ibuprofen, naproxen, oxycodone, morphine and hydromorphone and pharmaceutically acceptable salts thereof.  
   
   
       20 . The dosage form of  claim 16 , wherein the dosage form is capable of providing a plasma concentration within a therapeutic range of promethazine over a period which is coextensive with at least about 70% of a period over which the dosage form is capable of providing a plasma concentration within a therapeutic range of the at least one further drug.  
   
   
       21 . The dosage form of  claim 20 , wherein a plasma half-life of the at least one further drug is shorter than a plasma half-life of promethazine by at least about 3 hours.  
   
   
       22 . The dosage form of  claim 21 , wherein a period of a plasma concentration within the therapeutic range of the at least one further drug is coextensive with at least about 90% of a period of a plasma concentration within the therapeutic range of promethazine  
   
   
       23 . A pharmaceutical dosage form which comprises (a) at least one of promethazine and a pharmaceutically acceptable salt thereof in a first form or layer and (b) at least one of promethazine and a pharmaceutically acceptable salt thereof in a second form or layer which is different from the first form or layer, wherein the dosage form releases the promethazine (b) at least one of over a different period and at a different rate than the promethazine (a) and wherein the dosage form is capable of providing a promethazine plasma concentration within a therapeutic range for at least about 24 hours per single dose.  
   
   
       24 . The dosage form of  claim 23 , wherein the dosage form is a multi-layered tablet which comprises at least one immediate release layer and at least one controlled release layer and at least one of these layers comprises at least one of promethazine and a pharmaceutically acceptable salt thereof, and wherein at least one of the layers of the multi-layered tablet comprises at least one further drug.  
   
   
       25 . A pharmaceutical dosage form which comprises at least one of promethazine and a pharmaceutically acceptable salt thereof and at least one of pseudoephedrine and a pharmaceutically acceptable salt thereof, wherein the dosage form is capable of providing plasma concentrations within therapeutic ranges of both promethazine and pseudoephedrine for at least about 24 hours per single dose.  
   
   
       26 . The dosage form of  claim 25 , wherein the dosage form comprises a solid dosage form.  
   
   
       27 . The dosage form of  claim 26 , wherein the dosage form comprises a multi-layered tablet.  
   
   
       28 . The dosage form of  claim 25 , wherein the dosage form is capable of providing promethazine and pseudoephedrine plasma concentrations within therapeutic ranges within not more than about 1 hour following ingestion thereof.  
   
   
       29 . The dosage form of  claim 28 , wherein the dosage form comprises promethazine hydrochloride and pseudoephedrine hydrochloride.  
   
   
       30 . The dosage form of  claim 25 , wherein the dosage form comprises at least about 70 mg of promethazine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of promethazine.  
   
   
       31 . The dosage form of  claim 30 , wherein the dosage form comprises at least about 180 mg of pseudoephedrine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of pseudoephedrine per single dose.  
   
   
       32 . The dosage form of  claim 25 , wherein the dosage form comprises at least one further drug.  
   
   
       33 . The dosage form of  claim 1 , wherein the dosage form is associated with instructions to administer the dosage form once every 24 hours.  
   
   
       34 . The dosage form of  claim 23 , wherein the dosage form is associated with instructions to administer the dosage form once every 24 hours.  
   
   
       35 . The dosage form of  claim 25 , wherein the dosage form is associated with instructions to administer the dosage form once every 24 hours.  
   
   
       36 . A method of alleviating a condition which can be alleviated by administration of promethazine, wherein the method comprises administering the pharmaceutical dosage form of  claim 1  to a subject in need thereof.  
   
   
       37 . The method of  claim 36 , wherein the condition that can be alleviated by administration of promethazine comprises an allergic reaction.  
   
   
       38 . The method of  claim 37 , wherein the dosage form is administered not more than about once every 24 hours.  
   
   
       39 . A method of alleviating one or more conditions which can be alleviated by administration of promethazine and by administration of a drug which is at least one of a decongestant, an antitussive, an expectorant, a mucus thinning drug and an analgesic, wherein the method comprises administering the dosage form of  claim 17  to a subject in need thereof.  
   
   
       40 . The method of  claim 39 , wherein the dosage form is administered not more than about once every 24 hours.  
   
   
       41 . A method of alleviating one or more conditions which can be alleviated by administration of promethazine and pseudoephedrine, wherein the method comprises administering the dosage form of  claim 25  to a subject in need thereof.  
   
   
       42 . The method of  claim 41 , wherein the dosage form is administered not more than about once every 24 hours.  
   
   
       43 . A process for making the pharmaceutical dosage form of  claim 25 , wherein the process comprises preparing a first composition which comprises promethazine or a pharmaceutically acceptable salt thereof and a second composition which comprises pseudoephedrine or a pharmaceutically acceptable salt thereof, and combining the first and second compositions.  
   
   
       44 . The process of  claim 43 , wherein the compositions are combined by a method which comprises use of a tablet press.